FDA product code LLX: Catheter, Sampling, Chorionic Villus
LLX is the FDA product code for catheter, sampling, chorionic villus. It is a Class III device, reviewed by the Obstetrics and Gynecology panel. Devices under LLX reach the market by PMA; FDA lists no cleared 510(k)s for it. 2 PMA applications cite this product code.
Classification
| Field | Value |
|---|---|
| Device name | Catheter, Sampling, Chorionic Villus |
| Device class | Class III |
| Review panel | OB — Obstetrics and Gynecology |
| Medical specialty | Unknown |
| Premarket route | PMA |
Recalls for LLX devices
openFDA lists no recalls for product code LLX.
Frequently asked questions
What is FDA product code LLX?
LLX is the FDA product code for catheter, sampling, chorionic villus. It is a Class III device, reviewed by the Obstetrics and Gynecology panel.
What device class is LLX?
Class III. Typical premarket route: PMA.
Next steps
- Run an FDA pathway report with predicate devices for product code LLX
- Run a recall and safety report across every LLX manufacturer
- Watch product code LLX for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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